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The Effect of Osteopathic Manual Therapy on Vascular Supply

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Osteopathic evaluation
Osteopathic evaluation with treatment
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, manual therapy, osteopathy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Radiographic-confirmed knee osteoarthritis

Exclusion Criteria:

  • Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block
  • Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma))
  • Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis)
  • Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees
  • Subjects who have knee OA in only one knee and that knee has had previous knee surgery
  • Subjects who have previous vascular surgery to either leg

Sites / Locations

  • Capital District Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Osteopathic evaluation

Osteopathic evaluation with treatment

Arm Description

osteopathic evaluation of motion and tissue mobility

osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues

Outcomes

Primary Outcome Measures

Resistive Index (RI)
Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.

Secondary Outcome Measures

The Knee Flexion Active Range of Motion, Balance and Pain (VAS)

Full Information

First Posted
November 24, 2009
Last Updated
March 24, 2017
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01020591
Brief Title
The Effect of Osteopathic Manual Therapy on Vascular Supply
Official Title
The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine if the use of osteopathic manual therapy can influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a group of subjects with knee osteoarthritis. It is also the objective of this study to determine if there is a difference between the osteopathic evaluation and the combination of an osteopathic evaluation and treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, manual therapy, osteopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic evaluation
Arm Type
Active Comparator
Arm Description
osteopathic evaluation of motion and tissue mobility
Arm Title
Osteopathic evaluation with treatment
Arm Type
Experimental
Arm Description
osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Intervention Type
Other
Intervention Name(s)
Osteopathic evaluation
Intervention Description
evaluation of movement and tissue mobility
Intervention Type
Other
Intervention Name(s)
Osteopathic evaluation with treatment
Intervention Description
osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
Primary Outcome Measure Information:
Title
Resistive Index (RI)
Description
Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.
Time Frame
Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day
Secondary Outcome Measure Information:
Title
The Knee Flexion Active Range of Motion, Balance and Pain (VAS)
Time Frame
Jan 2010 to March 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radiographic-confirmed knee osteoarthritis Exclusion Criteria: Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma)) Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis) Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees Subjects who have knee OA in only one knee and that knee has had previous knee surgery Subjects who have previous vascular surgery to either leg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy M Jardine, MScPT
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Osteopathic Manual Therapy on Vascular Supply

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